Effectiveness and Safety of an Overnight Patch Containing Allium cepa Extract and Allantoin for Post-Dermatologic Surgery Scars

Abstract

Background: An occlusive overnight intensive patch medical device (OIP) containing onion extract and allantoin has been developed for preventing and treating dermatologic scars and keloids. Here, we examined the efficacy and safety of the OIP for post-dermatologic surgery scars.

Methods: This was an intra-individual randomized, observer-blind, controlled study in adults with post-dermatologic surgery scars. Two scars per subject were randomized to no treatment or overnight treatment with the OIP for 12-24 weeks. Scar quality was assessed using the Patient and Observer Scar Assessment Scale (POSAS) and a Global Aesthetic Improvement Scale.

Results: A total of 125 subjects were included. The decrease in observer-assessed POSAS from baseline was significantly greater for treated than untreated scars at week 6 (p < 0.001) and 24 (p = 0.001). The decrease in patient-assessed POSAS was significantly greater for the treated scar than the untreated scar at week 12 (p = 0.017) and 24 (p = 0.014). Subject- and investigator-evaluated Global Aesthetic Improvement Scale scores were higher for the treated than the untreated scar at all visits. All subjects considered the global comfort of the OIP to be good or very good, and no safety concerns were identified.

Conclusions: This study confirmed that the OIP safely promotes scar healing after minor dermatologic surgery.

Level of evidence ii: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Keywords: Allantoin; Dermatologic surgery; Onion extract; Patch; Scar; Skin.

Conflict of interest statement

W.P. has received research support and conducted clinical trials for Merz Pharmaceuticals, and he has acted as a speaker, investigator, or both for Merz Pharmaceuticals, Q-Med/Galderma, Allergan, Beiersdorf, SkinCeuticals, Cynosure, and Lumenis. G.G.G has received research support and conducted clinical trials for Merz Pharmaceuticals, and he has acted as a speaker, investigator, or both for Merz Pharmaceuticals, Galderma, Sinclair Pharma, Beiersdorf, Cynosure, Candela, Asclepion, Lumenis, Urgo GmbH, Almiral, and Johnson & Johnson.

Figures

Fig. 1

Disposition of subjects in the study. A total 125 adults who had undergone dermatologic surgery were included in the study. Two newly formed scars on each subject were randomized to treatment with the OIP or no treatment for at least 12 weeks, although subjects could choose to continue for 24 weeks

Fig. 2

Photographic images from a single subject’s scars at baseline (week 0) and weeks 6, 12, and 24. Abbreviation: OIP, overnight intensive patch

Fig. 3

Changes from baseline in observer-evaluated POSAS. At baseline and weeks 6, 12, and 24, blinded observers completed the observer-assessed POSAS. Values are for the full analysis set (N = 124). P values were determined by analysis of covariance with treatment and pooled site as fixed effect and subject as random effect and with the value at baseline as the covariate. Abbreviations: CI confidence interval, LS least square, OIP overnight intensive patch, POSAS Patient and Observer Scar Assessment scale

Fig. 4

Changes from baseline in patient-evaluated POSAS. At baseline and weeks 6, 12, and 24, study subjects completed the patient-assessed POSAS. Values are for the full analysis set (N = 124). P values were determined by analysis of covariance with treatment and pooled site as fixed effect and subject as random effect and with the value at baseline as the covariate. Abbreviations: CI confidence interval, LS least square, OIP overnight intensive patch, POSAS Patient and Observer Scar Assessment scale